Tralieve 80 mg Chewable Tablets for Dogs

Composition

Each tablet contains:

Active substance:

Tramadol 70.3 mg

(equivalent to 80 mg Tramadol hydrochloride)

Excipients:

Light brown with brown spots, round and convex flavoured 11 mm tablet with a cross-shaped break line on one side.

Tablets can be divided into 2 or 4 equal parts.

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Pharmacological properties

4.1 ATCvet code:

QN02AX02

4.2 Pharmacodynamics

Tramadol is a centrally acting analgesic agent with a complex mode of action exerted by its 2 enantiomers and primary metabolite, involving opioid, norepinephrine, and serotonin receptors. The (+) enantiomer of tramadol has a low affinity for the µ-opioid receptors, inhibits serotonin uptake and enhances its release.

The (-) enantiomer preferentially inhibits norepinephrine reuptake. The metabolite O-desmethyltramadol (M1) has greater affinity for the µ-opioid receptors.

Unlike morphine, tramadol does not have depressing effects on respiration for an extensive analgesic dose range. Likewise, it does not affect gastrointestinal motility. The effects on the cardiovascular system tend to be mild. The analgesic potency of tramadol is about 1/10 to 1/6 of that of morphine.

4.3 Pharmacokinetics

Tramadol is readily absorbed: After a single oral administration of 4.4 mg tramadol HCL per kg bodyweight, peak plasma concentrations of 65 ng tramadol per mL are achieved within 45 minutes. Food does not significantly affect the absorption of the drug.

Tramadol is metabolized in the liver by cytochrome P450 mediated demethylation followed by conjugation with glucuronic acid. In dogs, lower levels of the active metabolite O-desmethyltramadol are formed compared to humans. Elimination occurs mainly via the kidneys with an elimination half-life of about 0.5-2 hours.

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Target species

Dogs.

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Indications

For the reduction of acute and chronic mild soft tissue and musculoskeletal pain.

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Dosage

For oral use.

The recommended dose is 2-4 mg tramadol hydrochloride per kg body weight every 8 hours or as needed based on the intensity of pain.

Minimum dosing interval is 6 hours. The recommended maximum daily dose is 16 mg/kg. As the individual response to tramadol is variable and depends partly on the dosage, the age of the patient, individual differences in pain sensitivity and general condition, the optimal dosing regimen should be individually tailored using the above dose and re-treatment interval ranges. The dog should be examined regularly by a veterinarian to assess if additional analgesia is subsequently required. Additional analgesia can be administered by increasing the tramadol dose until the maximum daily dose is reached, and/or by following a multimodal analgesic approach with the addition of other suitable analgesics.

The most appropriate tablet strengths should be used in order to minimise divided tablets to be kept until the next dosing.

Please note that this dosing table is intended as a guide for dispensing the veterinary medicinal product at the high end of the dose range: 4 mg/kg bodyweight. It states the number of tablets required to administer 4 mg tramadol hydrochloride per kg bodyweight.

Tablets can be divided into 2 or 4 equal parts to ensure accurate dosing. Place the tablet on a flat surface, with its scored side facing up and the convex (rounded) side facing the surface.

2 equal parts: press down with your thumbs on both sides of the tablet.

4 equal parts: press down with your thumb in the middle of the tablet.

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Contraindications

Do not administer in conjunction with tricyclic antidepressants, monoamine oxidase inhibitors and serotonin reuptake inhibitors.

Do not use in cases of hypersensitivity to tramadol or to any of the excipients.

Do not use in animals with epilepsy.

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Adverse reactions

Dogs:

a Mild.

b Especially when higher doses are given.

c The treatment should be discontinued.

d In dogs with a low seizures threshold.

Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.

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Warnings

Special precautions for safe use in the target species:

Use with caution in dogs with renal or hepatic impairment. In dogs with hepatic impairment the metabolism of tramadol to the active metabolites may be decreased which may reduce the efficacy of the veterinary medicinal product. One of the active metabolites of tramadol is renally excreted and therefore in dogs with renal impairment the dosing regimen used may need to be adjusted. Renal and hepatic function should be monitored when using this veterinary medicinal product. Cessation of long-term analgesic therapy should be done gradually whenever possible.

Special precautions to be taken by the person administering the veterinary medicinal product to animals

People with known hypersensitivity to tramadol or any of the excipients should avoid contact with the veterinary medicinal product.

Tramadol may cause sedation, nausea and dizziness after accidental ingestion, especially by children. To avoid accidental ingestion, particularly by a child, unused tablet parts should be returned to the open blister space and inserted back into the carton and kept in a safe place out of the sight and reach of children as they pose a health risk to small children due to accidental ingestion. In case of accidental ingestion, particularly by children, seek medical advice and show the package leaflet or the label to the physician. In case of accidental ingestion by adults: DO NOT DRIVE as sedation may occur.

Wash hands after use.

Special precautions for the protection of the environment:

Not applicable.

3.11 Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance

Not applicable.

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Use during pregnancy, lactation or lay

Pregnancy:

Laboratory studies in mice and/or rats and rabbits have not produced any evidence of teratogenic, foetotoxic, maternotoxic effects. Use only according to the benefit-risk assessment by the responsible veterinarian.

Lactation:

Laboratory studies in mice and/or rats and rabbits have not produced any evidence of adverse effects in the peri- and postnatal development of offspring. Use only according to the benefit-risk assessment by the responsible veterinarian.

Fertility:

In laboratory studies in mice and/or rats and rabbits, the use of tramadol at therapeutic doses did not adversely affect reproductive performance and fertility in males and females. Use only according to the benefit-risk assessment by the responsible veterinarian.

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Interactions

Concomitant administration of the veterinary medicinal product with central nervous system depressants, may potentiate the CNS and respiratory depressant effects. Tramadol can increase the effect of drugs that lower the seizure threshold.

Drugs that inhibit (e.g. cimetidine and erythromycin) or induce (e.g. carbamazepine) CYP450 mediated metabolism may have an effect on the analgesic effect of tramadol. The clinical relevance of these interactions has not been studied in dogs. The combination with mixed agonist/antagonists (e.g. buprenorphine, butorphanol) and tramadol is not advisable, because the analgesic effect of a pure agonist may be theoretically reduced in such circumstances.

See also section 3.3.

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Overdose

In cases of intoxication with tramadol symptoms similar to those observed with other centrally acting analgesics (opioids) are likely to occur. These include in particular miosis, vomiting, cardiovascular collapse, consciousness disorders up to coma, convulsions and respiratory depression up to respiratory arrest.

General emergency measures: Maintain a patent airway, support cardiac and respiratory function depending on the symptoms. Inducing vomiting in order to empty the stomach is suitable unless the affected animal is showing reduced consciousness, in which case gastric lavage may be considered. The antidote for respiratory depression is naloxone. However, naloxone may not be useful in all cases of tramadol overdose as it may only partially reverse some of the other effects of tramadol. In case of seizures, administer diazepam.

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Special warnings

The analgesic effects of tramadol hydrochloride may be variable. This is thought to be due to individual differences in the metabolism of the drug to the primary active metabolite O-desmethyltramadol. In some dogs (non-responders) this may result in the veterinary medicinal product failing to provide analgesia. For chronic pain, multimodal analgesia should be considered. Dogs should be monitored regularly by a veterinarian to ensure adequate pain relief. In case of recurrence of pain or insufficient analgesia the analgesic protocol may need to be reconsidered.

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Withdrawal period

Not applicable

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Incompatibilities

Not applicable.

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Immediate packaging

Aluminium - PVC/PE/PVDC blister

Cardboard box of 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 or 25 blisters of 10 tablets.

Cardboard box containing 10 separate cardboard boxes, each containing 3 blister of 10 tablets.

Not all pack sizes may be marketed.

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Storage

Do not store above 30°C.

Store in the original package in order to protect from moisture.

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Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 2 years.

Shelf life of divided tablets after first opening the immediate packaging: 3 days.

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Disposal of unused product

Medicines should not be disposed of via wastewater.

Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and with any national collection systems applicable to the veterinary medicinal product concerned.

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Additional information

Vm 50406/5011

Vm 50406/3009

8 DATE OF FIRST AUTHORISATION

09 July 2018

9 DATE OF THE LAST REVISION OF THE SUMMARY OF THE PRODUCT CHARACTERISTICS

September 2024

10 CLASSIFICATION OF VETERINARY MEDICINAL PRODUCT

Veterinary medicinal product subject to prescription.

Find more product information by searching for the ‘Product Information Database’ on www.gov.uk.

Approved: 17 January 2025

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Registration holder

Dechra Regulatory B.V.

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